Fecal Microbiota Transplantation (FMT): PRIM-DJ2727 | NCT03786900

Studies
Fecal Microbiota Transplantation (FMT): PRIM-DJ2727

NCT03786900

Sponsor

Herbert DuPont, MD

Status

Available

Last Update Posted

Mar 9, 2026Actual

Enrollment

Not provided

Phase

Not provided

Conditions

Recurrent Clostridium Difficile Infection
Multidrug-resistant Klebsiella Pneumoniae Urinary Tract Infection

Interventions

Fecal Microbiota Transplantation (FMT) product PRIM-DJ2727

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2026

Overall Recruitment Status or Expanded Access Status

Available

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Not provided

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Dec 11, 2018

First Submission Date that Met QC Criteria

Dec 19, 2018

First Posted Date

Dec 26, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 5, 2026

Last Update Posted Date

Mar 9, 2026Actual

Description Module

Brief Summary

The Fecal Microbiota Transplantation (FMT) product PRIM-DJ2727 is prepared from human stool from a healthy, screened donor.

Requestors will contact the study team about the product (PRIM-DJ2727) by email, visit, or phone call. A screening list for donors will be provided to make sure that the list fits the requestor's requirements. A basic fee will be requested to recover the cost of making the product. After an agreement is made, a contract will be signed between the 2 parties. A week before the treatment, requestors will contact the study team for possible FMT product delivery. Delivery method will be confirmed for delivery by personnel (within 10 minutes driving distance) or by using FedEx services. Each delivered product will have an approved delivery form signed and dated by both the person who prepared the delivery and the person who received the package.

Detailed Description

Not provided

Design Module

Study Type

Expanded Access

Number of References to an Expanded Access Study

Expanded Access Types

Individual Patients

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

No data available

No data is available for this block.

Biospecimen

No data available

No data is available for this block.

Enrollment

Not provided

Name	Type	Description	Arm Group Labels	Other Names
Fecal Microbiota Transplantation (FMT) product PRIM-DJ2727	Biological

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Exclusion Criteria:

Accepts Healthy Volunteers

Not provided

Sex

Not provided

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Herbert L DuPont, MD	Contact	713 500 9366		herbert.l.dupont@uth.tmc.edu
Zhi-Dong Jiang, MD, DrPH	Contact	713-500-9371		zhi-dong.jiang@uth.tmc.edu

Overall Officials

Name	Affiliation	Role
Herbert DuPont, MD	The University of Texas Health Science Center, Houston	Principal Investigator

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003015	Clostridium Infections

Ancestor Terms

ID	Term
D016908	Gram-Positive Bacterial Infections
D001424	Bacterial Infections
D001423	Bacterial Infections and Mycoses
D007239	Infections

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000069467	Fecal Microbiota Transplantation

Ancestor Terms

ID	Term
D001691	Biological Therapy
D013812	Therapeutics

Browse Leaves

Not provided

Browse Branches

Not provided